SGLT2i exposure | N | Person-years | Severe renal disease cases | IR per 10 000 person-years | Adjusted HR (95% CI)* | P value* |
ITT | ||||||
Non-initiator | 43 852 | 90 437 | 1104 | 122.1 | 1.0 (ref) | |
SGLT2i initiator | 12 957 | 30 062 | 142 | 47.2 | 0.55 (0.46 to 0.67) | <0.01 |
OT | ||||||
Non-initiator | 43 852 | 81 643 | 1076 | 131.8 | 1.0 (ref) | |
SGLT2i initiator | 12 957 | 16 933 | 43 | 25.4 | 0.34 (0.25 to 0.47) | <0.01 |
AT | ||||||
Non-use | 46 522 | 85 758 | 1131 | 131.9 | 1.0 (ref) | |
Current use of SGLT2i | 18 469 | 29 681 | 72 | 24.3 | 0.31 (0.24 to 0.40) | <0.01 |
Recent use of SGLT2i | 9706 | 1565 | 10 | 63.9 | 0.70 (0.38 to 1.32) | 0.27 |
Past use of SGLT2i | 5963 | 3495 | 33 | 94.4 | 0.82 (0.58 to 1.17) | 0.28 |
Note that while ITT and OT categories are mutually exclusive, individuals might contribute to multiple AT categories during follow-up. Therefore, the sum of individuals contributing to each AT category exceeds the total number of individuals in the initial study cohorts.
*Adjusted estimates obtained using a Cox proportional hazards regression model including all variables in online supplemental table 1.
AT, as-treated; IR, incidence rate; ITT, intention-to-treat; OT, on-treatment; SGLT2i, sodium-glucose co-transporter-2 inhibitor.